NEW YORK – The European Commission has approved pembrolizumab (Merck's Keytruda) as a standalone treatment or paired with 5-FU chemotherapy as a first-line option for patients with metastatic or unresectable, recurrent head and neck cancer if their tumors have a PD-L1 combined positive score of 1 or more.
This approval will allow Merck, known as MSD outside of the US and Canada, to market pembrolizumab monotherapy and the combination regimen in 28 EU member states, as well as in Iceland, Lichtenstein and Norway. This is the first anti-PD-1 drug approved for first-line treatment of advanced forms of head and neck cancer, "a disease that has been treated the same way in the EU for more than a decade," Jonathan Cheng, VP of clinical research at Merck Research Laboratories, said in a statement.
The EC relied on data from the nearly 900-patient Phase III KEYNOTE-048 trial in which participants were stratified based on PD-L1 expression status. In the study, patients with a PD-L1 combined positive score of 1 or more and treated with pembrolizumab had a median overall survival of 12.3 months compared to 10.3 months for those on standard treatment. Median overall survival for patients with a PD-L1 combined positive score of 1 or more and who received pembrolizumab in combination with 5-FU had a median overall survival of 13.6 months versus 10.4 months on standard therapy.
"[Head and neck cancer] is especially debilitating since it can be highly visible and affect a patient’s appearance and their daily functions, such as eating and speaking," Kevin Harrington from the Institute of Cancer Research in London, who was also a study investigator, said in a statement. "Considering the great need for new treatment options, we are encouraged by today's [pembrolizumab] approval in Europe, which will allow certain patients to be treated with immunotherapy earlier in the course of their treatment."